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NCT02012465 · ClinicalTrials.gov registry record · Early Phase 1
Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT02012465: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT02012465 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02012465, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.
Primary Outcome
Defined as blood glucose \> 180 mg/dL. This will be measured as the % of patient-days with a blood sugar \> 180 mg/dL.
Interventions
- BIOLOGICAL Insulin protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-05 |
| Phase | Early Phase 1 |
What the finished NCT02012465 record still lists
NCT02012465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Insulin protocol is the first listed.
NCT02012465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02012465 about?
NCT02012465 is a clinical study titled "Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients". There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (...
What is the current status of trial NCT02012465?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2013-09. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02012465?
The interventions under investigation include: Insulin protocol (BIOLOGICAL).
Who is sponsoring clinical trial NCT02012465?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02012465's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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